E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
immuneresponse after vaccination |
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E.1.1.1 | Medical condition in easily understood language |
immuneresponse after vaccination |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
this study's objective is to follow the adaptive immuneresponse (on b and T cell level) enhanced by vaccination. The effect of vaccination in healthy voluneteers on: - induction of virus-specific antibodies - neutralising capabilities of the raised antibodies - the repertoire of the raised antibodies, inclusive epitope mapping by commercially available peptide arrays as in-house developed massspectrometry based bulk profiling of complementary determining regions of antibodies. - the creation of virusspecific memory T and B cells by detailled flowcytometric fenotyping - the possible negative effect of antibody mediated disease enhancement in an in vitro assay that allows measurement of target cel infection. - the subtype SARS-CoV-2 virus that despite vaccination still can lead to infection (viral whole genome sequencing)
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E.2.2 | Secondary objectives of the trial |
description of vaccin induced antibody dependent enhancement identification of vaccine escape mutants
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
healthy volunteer older than 18 years no infections at the time of vaccination and first blooddraw |
vrijwilliger zijn minstens 18 jaar en zijn gezond (vrij van elke vorm van infectie) bij eerste bloedafname en vaccinatie |
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E.4 | Principal exclusion criteria |
individuals infected with SARS-CoV-2 or have already been through a SARS-CoV-2 infection individuals with primary immunedeficiency. Individuals with immune modulating treatment individuals with an anuto immune disease pregnancy |
Individuen die geïnfecteerd zijn met SARS-CoV-2 of reeds SARS-CoV-2 infectie hebben doorgemaakt Individuen met een primaire immuundeficiëntie Individuen met immuunmodulerende behandeling Individuen met een autoimmuunziekte Zwangerschap
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E.5 End points |
E.5.1 | Primary end point(s) |
induction of virus-specific antibodies - neutralising capabilities of the raised antibodies - the repertoire of the raised antibodies, inclusive epitope mapping by commercially available peptide arrays as in-house developed massspectrometry based bulk profiling of complementary determining regions of antibodies. - the creation of virusspecific memory T and B cells by detailled flowcytometric fenotyping - the possible negative effect of antibory mediated disease enhancement in an in vitro assay that allows measurement of target cel infection. - the subtype SARS-CoV-2 virus that despite vaccination still can lead to infection (viral whole genome sequencing)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 14 |